Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 16
- Latest Decision
- 2026-09-29
Clearances · page 1 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K262553 | MOBILITY SCOOTER (YQ-401,YQ- 401A,YQ-403,YQ-403A) | Zhejiang Kailang Technology Co., Ltd. | INI | Class II | 2026-09-29 |
| K262241 | Electric Wheelchair (0080) | Xuzhou Heabens Medical Technology Co., Ltd. | ITI | Class II | 2026-09-29 |
| K262213 | Power Mobility Scooter (MA03) | Nanjing Mijo Technology Co., Ltd. | INI | Class II | 2026-09-29 |
| K262183 | Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60) | Shenzhen Nuon Medical Equipment Co., Ltd. | OAP | Class II | 2026-09-24 |
| K261078 | Electric Scooter (FNS01,FNS03) | Anhui Jbh Medical Apparatus Co., Ltd. | INI | Class II | 2026-09-24 |
| K262582 | Electric wheelchair (GP100) | Suzhou Green Pine Medical Co., Ltd. | ITI | Class II | 2026-09-23 |
| K262254 | Hair Growth Comb (X-GC01) | Guangdong Ashmore Health Technology Co., Ltd. | OAP | Class II | 2026-09-23 |
| K253762 | ErgoSteel (ES0001/696) | Strongback Mobility AG C/O Blueaudit GmbH | IOR | Class I | 2026-09-22 |
| K261859 | Electric Scooter (FDB08, FDB08A, FDB12) | Anhui JBH Medical Apparatus Co., Ltd. | INI | Class II | 2026-09-19 |
| K262054 | Electric Wheelchair | Yongkang Joymax Medical Technology Co., Ltd. | ITI | Class II | 2026-09-16 |
| K261919 | Multifunctional wheelchair (YJ-059) | Zhenjiang Assure Medical Equipment Co., Ltd. | IOR | Class I | 2026-09-16 |
| K260145 | YJ-K1K2 Wheelchair (YJ-013F) | Zhenjiang Assure Medical Equipment Co., Ltd. | IOR | Class I | 2026-09-15 |
| K260144 | Reclining wheelchair (YJ-013L) | Zhenjiang Assure Medical Equipment Co., Ltd. | IOR | Class I | 2026-09-15 |
| K260141 | Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C) | Zhenjiang Assure Medical Equipment Co., Ltd. | IOR | Class I | 2026-09-15 |
| K260229 | Electric wheelchair (HC819N, HC830N, HC831N) | Yongkang Hengyi Vehicle Co., Ltd. | ITI | Class II | 2026-09-08 |
| K260053 | Power Wheelchair (OS-R-M01I) | Beijing OrionStar Technology Co., Ltd. | ITI | Class II | 2026-09-08 |
| K254198 | Trexo Theo | Trexo Robotics, Inc. | PHL | Class II | 2026-09-02 |
| K262788 | Nova HD+ | Aura Wellness, LLC | SGT | Class II | 2026-08-31 |
| K261354 | Electric wheelchair (D03) | Foshan Sowell Medical Technology Co., Ltd. | ITI | Class II | 2026-08-21 |
| K253790 | High Intensity Focused Electromagnetic Stimulation Device (FE60) | Beijing Winkonlaser Technology Limited | NGX | Class II | 2026-08-13 |
| K260944 | ManaCold Compression System | Manamed, LLC | IRP | Class II | 2026-08-12 |
| K260094 | Mobility Scooter (W3465, W3902 (S50 Carbon)) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | INI | Class II | 2026-08-10 |
| K260176 | Mobility Scooter (W3483, W3483A) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | INI | Class II | 2026-08-10 |
| K261571 | Manual Wheelchair (H008, PCK7) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | IOR | Class I | 2026-08-06 |
| K260381 | Eve | Wandercraft SAS | PHL | Class II | 2026-08-03 |
| K260529 | Air Compression Massager (HY-1165) | Xiamen High Top Electronic Technology Co., Ltd. | IRP | Class II | 2026-07-27 |
| K250419 | Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow) | Plus EV Holdings, Inc. D/B/A Intimate Rose | OSD | Class II | 2026-07-27 |
| K260948 | Air Compression Massager (EP30B001 I) | Wavepulse (Xiamen) Healthcare Technology Co., Ltd. | IRP | Class II | 2026-07-24 |
| K252370 | GEN 4 JOY Wheelchair | Free Wheelchair Mission | IOR | Class I | 2026-07-24 |
| K261675 | CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D) | Shenzhen Chuanghong Zhilian Technology Co., Ltd. | OAP | Class II | 2026-07-17 |
| K261232 | IERO Mobility Scooter (IERO-01) | Jochu Technology Co., Ltd. | INI | Class II | 2026-07-14 |
| K261149 | Electric Wheelchair (DY611A-2, DY612A-1) | Zhejiang Lumbre Electric Appliance Co., Ltd. | ITI | Class II | 2026-07-10 |
| K261396 | Electric Wheelchair | Ningbo Resshidi Medical Devices Co., Ltd. | ITI | Class II | 2026-07-08 |
| K261164 | Electric wheelchair (XW-LY007 ) | Yongkang Ruihe Metal Product Co., Ltd. | ITI | Class II | 2026-07-07 |
| K261163 | Mobility Scooter (R200) | Yongkang Ruihe Metal Product Co., Ltd. | INI | Class II | 2026-07-07 |
| K261253 | Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, HR-I4, HR-I5) | Ziree Co., Ltd. | OAP | Class II | 2026-06-26 |
| K260937 | Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK) | Shanghai Waylong Intelligent Technology Co.,Ltd | ITI | Class II | 2026-06-24 |
| K261076 | Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02) | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. | IOR | Class I | 2026-06-22 |
| K261075 | Manual Wheelchair (MS01);Manual Wheelchair (MA01) | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. | IOR | Class I | 2026-06-22 |
| K253812 | Power Wheelchair (W5915B, W5915C, W5915D) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | ITI | Class II | 2026-06-18 |
| K260899 | Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159) | Zdeer Technology (Henan) Co., Ltd. | OAP | Class II | 2026-06-16 |
| K253231 | Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500) | Hubei Yjt Technology Co.,Ltd | OAP | Class II | 2026-06-16 |
| K260335 | Electric Wheelchair (S500-6) | Zhongshan Sulenz Intelligent Technology Co., Ltd. | ITI | Class II | 2026-06-15 |
| K261175 | WHILL (WHILL Model C2) | Whill, Inc. | ITI | Class II | 2026-06-12 |
| K252963 | BTL-899TT | BTL Industries, Inc. | IMJ | Class II | 2026-06-12 |
| K260849 | ICON 35; ICON 45; ICON 60; ICON 30FAF | Rehasense USA, Inc. | IOR | Class I | 2026-06-11 |
| K253919 | Cryo And Thermo Therapy System | Xiamen Weiyou Intelligent Technology Co., Ltd. | IRP | Class II | 2026-06-10 |
| K253542 | Apollo Quattro (APQ-10M) | Weero Co., Ltd. | IPF | Class II | 2026-06-08 |
| K253257 | Virgo Mobility Scooter (Virgo-D,Virgo-F) | Jiangsu Intco Medical Products Co., Ltd. | INI | Class II | 2026-06-08 |
| K260056 | Power Wheelchair (N5515A, N5516, N5517A, N5519) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | ITI | Class II | 2026-06-05 |
| K251684 | Alma TED+ System | Alma Lasers, Inc. | OAP | Class II | 2026-06-05 |
| K260373 | Electric Wheelchair (DF506) | Jiangsu Yveelt Medical Equipment Co., Ltd. | ITI | Class II | 2026-06-03 |
| K253600 | Scooter (YD-03) | Yurob Rehabilitation Medical Co., Ltd. | INI | Class II | 2026-06-03 |
| K260642 | Manual Wheelchair (LW01108) | Anhui Longway Medical Technology Co., Ltd. | IOR | Class I | 2026-06-02 |
| K252816 | High Tone Power therapy (HiToP) (Model: HiToP PNP) | Mohammadali Nezakati | IPF | Class II | 2026-06-02 |
| K252396 | Cryo Sport 2.0 (AVA 501) | Avanutri Equipamentos DE Saúde | IRP | Class II | 2026-05-29 |
| K260295 | Helio Kids; Apex P | Motion Composites | IOR | Class I | 2026-05-28 |
| K260142 | StimelMD (SSMD) system | Motion Informatics ltd. | IPF | Class II | 2026-05-27 |
| K254141 | Manual Wheelchair (DY01903(2)) | Guangdong Dayang Medical Technology Co., Ltd. | IOR | Class I | 2026-05-21 |
| K260717 | Mobility Scooter (Air Carbon) | Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. | INI | Class II | 2026-05-20 |
| K254024 | MR5 Activ Pro | Multi Radiance Medical, Inc. | NHN | Class II | 2026-05-19 |
| K253241 | Electric Wheelchair (Y207BL) | Jiangsu Intco Medical Products Co., Ltd. | ITI | Class II | 2026-05-13 |
| K254200 | Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1, LF-FT005-1, LF-FT006-1, LF-FT007, LF-FT008, LF-FT009, LF-FT010, LF-FT011, LF-FT012, LF-FT013, LF-FT014, LF-FT015, LF-FT016, UM-01, UM-02, UM-03, UM-03-1, UM-04-1, UM-05-1, UM-06-1, UM-07, UM-08, UM-09, UM-10, UM-11, UM-12, UM-13, UM-14, UM-15, UM-16, AI-01, AI-02, AI-03, AI-04, AI-05, AI-06, AI01, AI02, AI03, AI-07, AI-08, AI-09, AI-10, AI-11, AI-12, AI-13, AI-14) | Wenzhou Lingfeng Electronic Technology Co., Ltd. | IRP | Class II | 2026-05-05 |
| K253064 | Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air Pressure Therapy System (VU-IPC4X) | Xiamen Weiyou Intelligent Technology Co., Ltd. | IRP | Class II | 2026-04-30 |
| K260076 | SAM 3.0 Multi-Hour Continuous Ultrasound Device | ZetrOZ Systems, LLC | PFW | Class II | 2026-04-28 |
| K260121 | Manual Wheelchair (7101L, 7102LHD) | Foshan Nanhai Hongchen Medical Equipment Co., Ltd. | IOR | Class I | 2026-04-28 |
| K260237 | Mobility Scooter (X-12, X-14, X-17) | Wuyi Aichi Industry and Trade Co., Ltd. | INI | Class II | 2026-04-22 |
| K253806 | Power Wheelchair (N5919 series) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | ITI | Class II | 2026-04-20 |
| K253638 | xStep (xStep) | Spinex, Inc. | SDO | Class II | 2026-04-20 |
| K253926 | Diacore | ShenB Co., Ltd. | NGX | Class II | 2026-04-10 |
| K253952 | Power Wheelchair (OS-R-M01S) | Beijing OrionStar Technology Co., Ltd. | ITI | Class II | 2026-04-07 |
| K252386 | Hot and Cold Compression System (A02-C-032) | Chengdu Cryo-Push Medical Technology Co.,Ltd | IRP | Class II | 2026-04-03 |
| K253340 | Electric Wheelchair (AL-208S-063) | Zhongshan A&J Medical Equipment Co., Ltd. | ITI | Class II | 2026-04-03 |
| K253076 | Cryopush Cold Compression Device (A02-P-001) | Chengdu Cryo-Push Medical Technology Co.,Ltd | IRP | Class II | 2026-04-02 |
| K260319 | K5 wheelchair (16 with swing-away footrest 18 with swing-away footrest 20 with swing-away footrest 16 with elevated foot rest(ELR) 18 with elevated foot rest(ELR) 20 with elevated foot rest(ELR)) | Zhenjiang Assure Medical Equipment Co., Ltd. | IOR | Class I | 2026-03-31 |
| K253307 | Electric wheelchair | Foshan Dahao Medical Technology Co., Ltd. | ITI | Class II | 2026-03-27 |
| K254206 | Power wheelchair (ZS-EW8026) | Ningbo Zhishan Medical Technology Co., Ltd. | ITI | Class II | 2026-03-27 |
| K252893 | ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013) | Aneuvo | SDO | Class II | 2026-03-27 |
| K253980 | Electrically Powered Wheelchair (Model YC-01) | Yurob Rehabilitation Medical Co., Ltd. | ITI | Class II | 2026-03-27 |
| K254012 | Electric Wheelchair (E201) | Nanjing CareMoving Rehabilitation Equipment Co.,Ltd | ITI | Class II | 2026-03-24 |
| K253849 | Electric wheelchair (JJW-7002, JJW-7003) | ZheJiang J&J Mobility Co., Ltd. | ITI | Class II | 2026-03-20 |
| K252101 | JWG-1 | Yamaha Motor Co., Ltd. | ITI | Class II | 2026-03-19 |
| K253965 | CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.) | Wuhan PHOMED Technology Company , Ltd. | ILY | Class II | 2026-03-19 |
| K252813 | Electrical Scooter (SM4226) | Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd. | INI | Class II | 2026-03-17 |
| K253581 | Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005) | Technomed Europe | IKT | Class II | 2026-03-15 |
| K253636 | Zionic Pro Max (EMS) | Termosalud S.L. | NGX | Class II | 2026-03-12 |
| K253936 | Power Mobility Scooter (MJMA01, MJMA02) | Nanjing Mijo Technology Co., Ltd. | INI | Class II | 2026-03-12 |
| K253870 | Electric Wheelchair (MP148) | Suzhou Master Machinery Manufacturing Co.,Ltd | ITI | Class II | 2026-03-04 |
| K253789 | Electric wheelchair | Zhejiang Yikang Medical Technology Co., Ltd. | ITI | Class II | 2026-02-25 |
| K253707 | Electric wheelchair (W1,W3) | Shenzhen Zhimahuaerkai Technology Co., Ltd. | ITI | Class II | 2026-02-24 |
| K253631 | Mobility Scooter (CL-Q3, CL-Q4) | Zhejiang Wei Ling New Energy Technology Co., Ltd. | INI | Class II | 2026-02-23 |
| K251903 | Erchonia DPN Laser (Model# EVRL) | Erchonia Corporation | NHN | Class II | 2026-02-19 |
| K253643 | Mobility Scooter (S3) | Shenzhen Zhimahuaerkai Technology Co., Ltd. | INI | Class II | 2026-02-18 |
| K253599 | Electric Wheelchair (W-A807, W-A807L) | Ningbo Shenyu Medical Equipment Co.,Ltd | ITI | Class II | 2026-02-17 |
| K252347 | Electric Scooter (Mojo-T580) | Dongguan Smarfody Mobility Technology Co., Ltd. | INI | Class II | 2026-01-29 |
| K253632 | Manual Wheelchair (W50) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | IOR | Class I | 2026-01-29 |
| K252275 | Electric Scooter (DDF100) | Zhejiang Nysin Medical Co., Ltd. | INI | Class II | 2026-01-29 |
| K252349 | Electric Scooter (Mojo-T330) | Dongguan Smarfody Mobility Technology Co., Ltd. | INI | Class II | 2026-01-29 |
| K251622 | Hand Massager (SM004D) | Ningbo Zhenhai Yihao Electronic Technology Co., Ltd. | IRP | Class II | 2026-01-28 |
| K253669 | TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | OAP | Class II | 2026-01-23 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.